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Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rosacea

Intervention: Metronidazole gel 1% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, LP

Summary

This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application.

Clinical Details

Official title: MetroGel 1% Hydration Study: A Kinetic Regression Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Six replicate Corneometer CM 825 measurements

Secondary outcome: Adverse events

Detailed description: This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application as measured by the Corneometer CM 825.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of moderate to severe rosacea, defined as the presence of at least

moderate erythema with telangiectasia and a minimum of two inflammatory lesions Exclusion Criteria:

- Individuals with active symptoms of allergy (mild active seasonal allergies are

acceptable) or atopic dermatitis

Locations and Contacts

Colorado Springs Research Center, Colorado Springs, Colorado 80915, United States
Additional Information

Starting date: August 2006
Last updated: April 11, 2008

Page last updated: August 23, 2015

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